DETAILED ACTION
Claims 31-33, 35-40 and 49 are currently pending in the instant application and are rejected.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11 March 2026 has been entered.
Terminal Disclaimer
The terminal disclaimer filed on 11 March 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of the full statutory term of prior patent numbers 12377112, 12433904, 12447164, and the full statutory term of any patent granted on Application No. 19296543, 19296350, and 19296560 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Amendment and Arguments
Applicant's amendment and arguments filed 11 March 2026 have been fully considered and entered into the instant application. Applicant’s amendment has overcome the 35 USC 102(a)(1) as anticipated by or, in the alternative, under 35 USC 103 as obvious over Folen, J Forensic Sci. Apr. 1975, Vol 20, No. 2, pages 348-372 (Reference cite no. 815, NPL documents IDS filed 4/25/2024) and has overcome the 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hofmann, A. et al., 1959, Psilocybin und Psilocyn, Zwei psychotrope Wirkstoffe aus mexikanishen Rauschpizen. HCA, 42: 1557-1572 (Reference Cite no. 991, NPL documents IDS filed 4/25/2024) as applicant has amended claim 31 to include the limitation of now canceled claim 34. US Patent Application 19/296,581 is now US Patent No. 12,611,418, issued 28 April 2026, therefore, the provisional double patenting rejection is modified to a double patenting rejection and maintained over now US Patent No. 12,611,418. As there is a pending and proper nonstatutory double patenting rejection over US Patent No. 12,611,418, the provisional double patenting rejections over US Patent Application No.’s 18/703,950; 18/718,103; and 19/234,582 are maintained. As US Patent Application 17/604,610 is abandoned, this provisional double patenting rejection is withdrawn. Additionally, as there is a pending and proper nonstatutory double patenting rejection over US Patent No. 12,611,418, the following new provisional double patenting rejections are provided over US Patent Applications 19/661,190; 19/629,952; 19/423,663; 19/661,115; and 19/569,250.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 31-33, 35-40 and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,611,418. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods of treating a bipolar disorder with psilocybin with XRPD peaks at 11.5, 12.0, 14.5, 17.5, and 19.7. Conflicting claim 16 provides additional XRPD peaks. Applicant’s instant claims are product-by-process claims wherein the product is crystalline psilocybin having no single impurity greater than 1% (instant claims 31, 40 and 49), having less than 1% psilocin (instant claim 32), having less than 0.5% psilocin (instant claim 33), with specific XRPD peaks including peaks at 17.5+/-0.1 and 19.7 +/-0.1 (instant claims 31 and 35), wherein the crystalline psilocybin has a chemical purity of greater than 97% (instant claim 36), chemical purity of greater than 98% (instant claim 37), greater than 99% (instant claim 38), with a melting point of about 205 to 220 degrees Celsius (instant claim 39). The conflicting claims are drawn to methods of use of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7 which reads on the instantly claimed crystalline psilocybin having no single impurity greater than 1% of the instant claims. The method claims of the ‘418 patent anticipate Applicant’s instant product-by-process claims to crystalline psilocybin having no single impurity greater than 1%.
Claim 31-33, 35-40 and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14, 17-18, 23-26, 50, 51, 54 and 55 of copending Application No. 18/703,950 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods of treating treatment resistant depression with psilocybin. Conflicting claim 23 provides crystalline psilocybin with specific XRPD peaks including 17.5 and 19.7. Conflicting claim 24 provides chemical purity of greater than 97%. Conflicting claim 25 provides no single impurity greater than 2%. Applicant’s instant claims are product-by-process claims wherein the product is crystalline psilocybin having no single impurity greater than 1% (instant claims 31, 40 and 49), having less than 1% psilocin (instant claim 32), having less than 0.5% psilocin (instant claim 33), with specific XRPD peaks including peaks at 17.5+/-0.1 and 19.7 +/-0.1 (instant claims 31 and 35), wherein the crystalline psilocybin has a chemical purity of greater than 97% (instant claim 36), chemical purity of greater than 98% (instant claim 37), greater than 99% (instant claim 38), with a melting point of about 205 to 220 degrees Celsius (instant claim 39). The conflicting claims are drawn to methods of use of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7, having a chemical purity of greater than 97% and no single impurity of greater than 2% which reads on the instantly claimed crystalline psilocybin having no single impurity greater than 1% of the instant claims. The method claims of the ‘950 application anticipate Applicant’s instant product-by-process claims to crystalline psilocybin having no single impurity greater than 1%.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 31-33, 35-40 and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22, 25-27, 29, 34-37, and 46-47 of copending Application No. 18/718,103 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods of treating treatment resistant depression with psilocybin. Conflicting claims 46 and 47 provides crystalline psilocybin with specific XRPD peaks including 17.5 and 19.7. Applicant’s instant claims are product-by-process claims wherein the product is crystalline psilocybin having no single impurity greater than 1% (instant claims 31, 40 and 49), having less than 1% psilocin (instant claim 32), having less than 0.5% psilocin (instant claim 33), with specific XRPD peaks including peaks at 17.5+/-0.1 and 19.7 +/-0.1 (instant claims 31 and 35), wherein the crystalline psilocybin has a chemical purity of greater than 97% (instant claim 36), chemical purity of greater than 98% (instant claim 37), greater than 99% (instant claim 38), with a melting point of about 205 to 220 degrees Celsius (instant claim 39). The conflicting claims are drawn to methods of use of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7 which reads on the instantly claimed crystalline psilocybin having no single impurity greater than 1% of the instant claims. The method claims of the ‘103 application anticipate Applicant’s instant product-by-process claims to crystalline psilocybin having no single impurity greater than 1%.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 31-33, 35-40 and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/234,582 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods of treating a neurocognitive disorder with psilocybin with XRPD peaks at 11.5, 12.0, 14.5, 17.5, and 19.7. Conflicting claim 8 provides no single impurity of greater than 1%. Applicant’s instant claims are product-by-process claims wherein the product is crystalline psilocybin having no single impurity greater than 1% (instant claims 31, 40 and 49), having less than 1% psilocin (instant claim 32), having less than 0.5% psilocin (instant claim 33), with specific XRPD peaks including peaks at 17.5+/-0.1 and 19.7 +/-0.1 (instant claims 31 and 35), wherein the crystalline psilocybin has a chemical purity of greater than 97% (instant claim 36), chemical purity of greater than 98% (instant claim 37), greater than 99% (instant claim 38), with a melting point of about 205 to 220 degrees Celsius (instant claim 39). The conflicting claims are drawn to methods of use of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7 and no single impurity of greater than 1% which reads on the instantly claimed crystalline psilocybin having no single impurity greater than 1% of the instant claims. The method claims of the ‘582 application anticipate Applicant’s instant product-by-process claims to crystalline psilocybin having no single impurity greater than 1%.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 31-33, 35-40 and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-162 of copending Application No. 19/423,663 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to products and methods of treatment with psilocybin. Conflicting claim 35 provides the treatment of depression with polymorph A, which has no single impurity of greater than 1% (conflicting claim 36) and purity greater than 97% by HPLC. Conflicting claim 43 provides no single impurity greater than 0.5%. Conflicting claim 109 claims crystalline psilocybin as described in the ‘663 application. Conflicting claims 130-133 provide crystalline polymorph A of psilocybin. Applicant’s instant claims are product-by-process claims wherein the product is crystalline psilocybin having no single impurity greater than 1% (instant claims 31, 40 and 49), having less than 1% psilocin (instant claim 32), having less than 0.5% psilocin (instant claim 33), with specific XRPD peaks including peaks at 17.5+/-0.1 and 19.7 +/-0.1 (instant claims 31 and 35), wherein the crystalline psilocybin has a chemical purity of greater than 97% (instant claim 36), chemical purity of greater than 98% (instant claim 37), greater than 99% (instant claim 38), with a melting point of about 205 to 220 degrees Celsius (instant claim 39). The conflicting claims are drawn to methods of use of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7 and no single impurity of greater than 1% which reads on the instantly claimed crystalline psilocybin having no single impurity greater than 1% of the instant claims. The claims of the ‘663 application anticipate Applicant’s instant product-by-process claims to crystalline psilocybin having no single impurity greater than 1%.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 31-33, 35-40 and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 19/569,250 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to a method of treating a substance disorder with crystalline psilocybin with peaks at 11.5, 12.0, 14.5, 17.5, and 19.7 +/- 0.1 XRPD (conflicting claims 1 and 20) with a chemical purity of greater than 97%. Conflicting claims 18 and 29 provide additional XRPD peaks. Conflicting claims 19 and 30 provides no single impurity greater than 1%. Applicant’s instant claims are product-by-process claims wherein the product is crystalline psilocybin having no single impurity greater than 1% (instant claims 31, 40 and 49), having less than 1% psilocin (instant claim 32), having less than 0.5% psilocin (instant claim 33), with specific XRPD peaks including peaks at 17.5+/-0.1 and 19.7 +/-0.1 (instant claims 31 and 35), wherein the crystalline psilocybin has a chemical purity of greater than 97% (instant claim 36), chemical purity of greater than 98% (instant claim 37), greater than 99% (instant claim 38), with a melting point of about 205 to 220 degrees Celsius (instant claim 39). The conflicting claims are drawn to methods of use of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7 and no single impurity of greater than 1% which reads on the instantly claimed crystalline psilocybin having no single impurity greater than 1% of the instant claims. The method claims of the ‘250 application anticipate Applicant’s instant product-by-process claims to crystalline psilocybin having no single impurity greater than 1%.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 31-33, 35-40 and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 19//629,952 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are claiming processes or preparation of products of crystalline psilocybin with x-ray peaks at 17.5, 11.5, 12.0, 14.5 and 19.7 (conflicting claim 3) which has no single impurity greater than 1% (conflicting claim 5). Conflicting claim 14 provides additional peaks. Applicant’s instant claims are product-by-process claims wherein the product is crystalline psilocybin having no single impurity greater than 1% (instant claims 31, 40 and 49), having less than 1% psilocin (instant claim 32), having less than 0.5% psilocin (instant claim 33), with specific XRPD peaks including peaks at 17.5+/-0.1 and 19.7 +/-0.1 (instant claims 31 and 35), wherein the crystalline psilocybin has a chemical purity of greater than 97% (instant claim 36), chemical purity of greater than 98% (instant claim 37), greater than 99% (instant claim 38), with a melting point of about 205 to 220 degrees Celsius (instant claim 39). The conflicting claims are drawn to processes of preparing products of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7 and no single impurity of greater than 1% which reads on the instantly claimed crystalline psilocybin having no single impurity greater than 1% of the instant claims. The process claims of the ‘952 application anticipate Applicant’s instant product-by-process claims to crystalline psilocybin having no single impurity greater than 1%.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 31-33, 35-40 and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 19/661,115 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods of treating treatment-resistant depression with a solid pharmaceutical composition comprising 25mg of psilocybin (conflicting claim 1) with peaks at 17.4, 11.5, 12.0, 14.5 and 19.7 in conflicting claim 9. Conflicting claim 10 provides additional peaks. Conflicting claim 11 claims the solid pharmaceutical composition of 25mg psilocybin. Conflicting claims 18 and 19 provide XRPD peaks. Applicant’s instant claims are product-by-process claims wherein the product is crystalline psilocybin having no single impurity greater than 1% (instant claims 31, 40 and 49), having less than 1% psilocin (instant claim 32), having less than 0.5% psilocin (instant claim 33), with specific XRPD peaks including peaks at 17.5+/-0.1 and 19.7 +/-0.1 (instant claims 31 and 35), wherein the crystalline psilocybin has a chemical purity of greater than 97% (instant claim 36), chemical purity of greater than 98% (instant claim 37), greater than 99% (instant claim 38), with a melting point of about 205 to 220 degrees Celsius (instant claim 39). The conflicting claims are drawn to products of crystalline psilocybin with specific XRPD peaks and methods of treating treatment resistant depression which reads on the instantly claimed crystalline psilocybin having no single impurity greater than 1% of the instant claims. The process claims of the ‘115 application anticipate Applicant’s instant product-by-process claims to crystalline psilocybin having no single impurity greater than 1%.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 31-33, 35-40 and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending Application No. 19/661,190 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to products of crystalline psilocybin with XRPD peaks at 17.5, 11.5, 12.0, 14.5 and 19.7 (conflicting claim 1). Conflicting claims 2 and 3 provide additional XRPD peaks along with conflicting claims 15-17. Conflicting claims 6 and 20 provide no single impurity of greater than 1% as determined by HPLC analysis. Applicant’s instant claims are product-by-process claims wherein the product is crystalline psilocybin having no single impurity greater than 1% (instant claims 31, 40 and 49), having less than 1% psilocin (instant claim 32), having less than 0.5% psilocin (instant claim 33), with specific XRPD peaks including peaks at 17.5+/-0.1 and 19.7 +/-0.1 (instant claims 31 and 35), wherein the crystalline psilocybin has a chemical purity of greater than 97% (instant claim 36), chemical purity of greater than 98% (instant claim 37), greater than 99% (instant claim 38), with a melting point of about 205 to 220 degrees Celsius (instant claim 39). The conflicting claims are drawn to products of crystalline psilocybin with specific XRPD peaks having no single impurity greater than 1% of the instant claims. The product claims of the ‘190 application anticipate Applicant’s instant product-by-process claims to crystalline psilocybin having no single impurity greater than 1%.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 24 June 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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